MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA ULTRA 360 PATIENT POSITIONING SYSTEM; N/A

Model Number	A2009
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The a2009 ultra 360 patient positioning system was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - unit received with upper and lower handles out of adjustment.Both shock cushions were replaced due to wear.The unit was received with the standard adaptor and not the tri-star adaptor.General maintenance and cleaning required.Readjustment of both handles and replacement of worn shock cushions.Root cause - the reported complaint was confirmed.Unit received showing signs of routine wear.Both handles required readjustment and both shock cushions needed replaced due to wear.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
Event or Problem Description
A facility reported that the latch closest to the head on the ultra 360 patient positioning system (a2009) was not as tight as it should be.There was no patient involvement and no delay in starting case, as it was discovered during inspection.

• Brand Name: ULTRA 360 PATIENT POSITIONING SYSTEM
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• MDR Report Key: 12291491
• Report Number: 3004608878-2021-00490
• Device Sequence Number: 11554738
• Product Code: FWZ
• UDI-Device Identifier: 10381780267850
• UDI-Public: 10381780267850
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A2009
• Device Catalogue Number: A2009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1